Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.1.6 - Reconciliation + Stage 2 Connectathon United States of America flag

Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.1.6 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions

PlanDefinition: A quality specification is for a drug product

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/PlanDefinition/aa514363-d43f-4052-b44e-b67aa4d6dee7 Version: 1.1.6
Active as of 2022-12-08 Computable Name:
Other Identifiers: ExampleSpecification, OID:2.16.840.1.113883.4.642.40.36.34.4

Generated Narrative: PlanDefinition aa514363-d43f-4052-b44e-b67aa4d6dee7

Specification Status: Not Approved

url: PlanDefinition Quality Specification for OXAZEPAM

identifier: ExampleSpecification, Uniform Resource Identifier (URI)/urn:oid:2.16.840.1.113883.4.642.40.36.34.4

version: 1.1.6

title: Quality Specification for OXAZEPAM

type: Workflow Definition

status: Active

subject: Bundle: identifier = UUID:34a0748d-b199-4a2e-a5bc-0f880886fef7; type = document; timestamp = 2023-12-15 22:33:13+0000

date: 2022-12-08

publisher: HL7 International / Biomedical Research and Regulation

contact: HL7 International / Biomedical Research and Regulation: http://www.hl7.org/Special/committees/rcrim,brr@lists.HL7.org

jurisdiction: United States of America

goal

id

32649771-1290-4386-9cf7-7a72274f22b4

description: Average of 10 between 2-3 pH

addresses: Release, Stability

Targets

-ModifierExtension
*

goal

id

59a4ca76-858e-4d58-8e5f-88e75f51ec33

description: Maxima only at the same wavelengths compared to reference standard

addresses: Release, Stability

Targets

-Detail[x]
*Conforms

goal

id

c40aa176-e6aa-4fe4-869d-6550ee992903

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addresses: Release, Stability

Targets

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goal

id

b122987d-586c-481b-951c-6202e660158d

description: Color of solution is clear

addresses: Release, Stability

Targets

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goal

id

929747ad-e83a-46f0-bbbc-133ee951e819

description: <= 0.05 %

addresses: Release, Stability

Targets

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goal

id

8d7c85c2-7a4b-432e-ac94-226f296e4fca

description: No Particulate Matter detected

addresses: Release, Stability

Targets

-Detail[x]
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goal

id

de4f962a-d486-486d-8d84-f2d1635646b4

description: <= 0.014 %

addresses: Release, Stability

Targets

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*<=0.014 percent (Details: UCUM code% = '%')

goal

id

b46dce64-a009-46cd-ab95-21d1d5b4df77

description: <= 0.04 %

addresses: Release, Stability

Targets

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goal

id

5566f501-37e1-49fb-8783-b20c074ec0c3

description: <= 0.001 %

addresses: Release, Stability

Targets

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goal

id

db19e3ab-e28b-4477-8bd7-2409093ed5a3

description: Color intenssity of feriric ammonium sulfate TS is not less that than salicylic acid (0.1%) solution

addresses: Release, Stability

Targets

-Detail[x]
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goal

id

82370588-7aae-4556-9262-a7f50dbd01aa

description: Ethanol < 0.2%

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Targets

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goal

id

cae2da87-c4b7-43d0-9e8e-c64d0d4df6c2

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Targets

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goal

id

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addresses: Release

Targets

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goal

id

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Targets

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goal

id

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Targets

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*

goal

id

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addresses: Release

Targets

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goal

id

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description: Each unit is NLT Q + 5%

addresses: Release

Targets

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*<=85 percent (Details: UCUM code% = '%')

goal

id

47c0d685-0b23-4637-9af8-a554e4fad7ec

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Targets

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goal

id

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target

measure: Average of 12 units

detail: <=80 percent (Details: UCUM code% = '%')

target

measure: unit

detail: <=65 percent (Details: UCUM code% = '%')

goal

id

15309a78-92a9-4cf9-aee1-452d6d2f7a91

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target

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target

measure: units less than Q – 15%

detail: <=2 Amb a 1 units (Details: UCUM code[Amb'a'1'U] = '[Amb'a'1'U]')

target

measure: units less than Q – 25%

detail: <=0 Amb a 1 units (Details: UCUM code[Amb'a'1'U] = '[Amb'a'1'U]')

goal

id

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addresses: Release

Targets

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action

id

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prefix: Single Stage

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Alternate

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Documentations

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Documentations

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Documentations

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Documentations

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Documentations

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